510(k) Report

Devices descending from K133037

6 later devices reach Grindguard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181099Bright GuardKoncept Innovators, LLC20195—
+2K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+2K221369FBCC Night GuardFbcc, Inc.20223—
+3K252004enCore Night GuardEncore Guards20250—
+3K251778Remi Custom Night GuardRemi20251—
+4K253641Owl Night GuardOwl Dental Lab, Inc.20260—